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General information
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2024-02-22, 1402/12/03
2024-02-22 00:00:00
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2024-07-15, 1403/04/25
2024-07-15 00:00:00
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The actual recruitment start and end date were added.
The actual recruitment start and end date were added.
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تاریخ واقعی شروع و پایان بیمارگیری اضافه شد.
تاریخ واقعی شروع و پایان بیمارگیری اضافه شد.
Protocol summary
Study aim
The aim of this study is to investigate the amount of postoperative pain and analgesic drug consumption in patients with supraorbital and infraorbital nerve block (BSIB) by bupivacaine, after rhinoplasty surgery.
Design
A three-blind randomized clinical trial study with one control group and three intervention groups with parallel groups on 200 patients (each group 50 people). The random block method will be used for randomization.
Settings and conduct
Khalili Hospital and Bo Ali Sina Hospital affiliated to Shiraz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Primary rhinoplasty will be performed in all patients with standard technique and oblique lateral-medial osteotomy. Patients whose physical condition was ASA I based on the American Anesthesiology classification (ASA) and between 17 and 50 years of age will be included in the study.
Exclusion criteria are: lack of consent to participate in the study, patients with cardiovascular problems, history of sensitivity to bupivacaine, receiving other anesthetics before and during surgery, and cognitive disorders and inability to communicate and express the level of pain.
Intervention groups
Patients who will undergo primary rhinoplasty.
Main outcome variables
The amount of nasal pain, the use of analgesics, the amount of nausea-vomiting and postoperative complications
General information
Reason for update
The actual recruitment start and end date were added.
Acronym
IRCT registration information
IRCT registration number:IRCT20131020015083N5
Registration date:2024-02-07, 1402/11/18
Registration timing:prospective
Last update:2025-04-24, 1404/02/04
Update count:1
Registration date
2024-02-07, 1402/11/18
Registrant information
Name
Amir Hossein Babaei
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 739 5073
Email address
babaei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
2024-02-22, 1402/12/03
Actual recruitment end date
2024-07-15, 1403/04/25
Trial completion date
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Scientific title
Investigating the effect of injectable and topical Bupivacaine on post operative pain after rhinoplasty
Public title
Investigating the effect of Bupivacaine on post operative pain after rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I physical status based on the American Classification of Anesthesiology (ASA)
Age between 17 and 50 years
Performing primary rhinoplasty with standard technique and oblique lateral-medial osteotomy
Exclusion criteria:
Not agreeing to participate in the study
Patients with cardiovascular disease
History of sensitivity to bupivacaine
Receiving other anesthetics before and during the operation
Cognitive disorders and the inability to communicate and express the level of pain
Age
From 17 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Actual sample size reached:
55
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to injection (number 0 in select case) or topical (number 1 in select case), combined (number 2 in select case), and control (number 3 in select case) groups (1:1:1:1 ratio) using random numbers which were generated through computerized block randomization using SPSS software version 23. To reduce selection bias and confounding factors, randomization was performed by a single appointed researcher who did not participate in data collection.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant, Care provider, Investigator, Outcome assessor, Data analyser, and Data and Safety Monitoring Board were unaware of the intervention and allocation of treatments until the statistical analysis was complete.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences - Zand street
City
Shiraz
Province
Fars
Postal code
71345-1583
Approval date
2024-01-16, 1402/10/26
Ethics committee reference number
IR.SUMS.MED.REC.1402.477
Health conditions studied
1
Description of health condition studied
patients underwent rhinoplasty
ICD-10 code
Z42
ICD-10 code description
Encounter for plastic and reconstructive surgery following medical procedure or healed injury
Primary outcomes
1
Description
Degree of nasal pain
Timepoint
1 hour after the operation, 6 hours after the operation, 1 day after the operation, 2 days after the operation and 3 days after the operation
Method of measurement
Visual analog scale (VAS)
2
Description
analgesic consumption
Timepoint
1 hour after the operation, 6 hours after the operation, 1 day after the operation, 2 days after the operation and 3 days after the operation
Method of measurement
Asking the patient directly and recording analgesic consumption
Secondary outcomes
1
Description
Nausea-vomiting
Timepoint
1 hour after the operation, 6 hours after the operation, 1 day after the operation, 2 days after the operation and 3 days after the operation
Method of measurement
Visual analog scale
2
Description
Postoperative complications
Timepoint
up to 7 days
Method of measurement
direct physical examination
Intervention groups
1
Description
patients who at the end of the operation (before the patient regains consciousness) will be injected with bupivacaine (Marcaine® 0.5%: Aspen Japan; Tokyo, Japan) with a total volume of 4 ml as a local anesthetic.
Category
Prevention
2
Description
Intervention group:There are patients who will be administered local anesthetic bupivacaine (Marcaine® 0.5%: Aspen Japan; Tokyo, Japan) with a total volume of 4 ml at the beginning of the procedure.
Category
Prevention
3
Description
Intervention group: There are patients who receive local bupivacaine through the mesh (each mesh 1 cc, 2 cc in total) at the beginning of the procedure and bupivacaine injection (0.5 cc in each point, 2 cc in total) at the end of the procedure (a total of 4 cc of bupivacaine).
Category
Prevention
4
Description
Control group: No local anesthesia will be used
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ear, Nose and Throat Clinic, Khalili Hospital
Full name of responsible person
Dr Reza Kaboodkhani
Street address
khalili street
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3629 1470
Fax
Email
kaboodkhani@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hashem Hashempour
Street address
Karim Khan Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Fax
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
What processes are involved for a request to access data/document
the request should be sent by email (containing personal and professional information), describing their study protocol, after approving their identity and proposal, the data will be sent by email.